The text starts here.

News Release

FOR IMMEDIATE RELEASE
April 17, 2002

VASCULAR DEMENTIA PHASE III CLINICAL TRIAL RESULTS FOR ARICEPT R, AN ALZHEIMER'S DISEASE TREATMENT,
ANNOUNCED AT AN ACADEMIC CONFERENCE

Denver (April 17, 2002) - Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) announced results of the second of two phase three clinical trials conducted in the U.S. and Europe by Eisai Inc. (President: William Sheldon) involving vascular dementia (VaD) for ARICEPT R which were presented at the 54th Annual Meeting of the American Academy of Neurology (AAN) in Denver, Colorado. The data presented at the AAN, reinforces findings from an earlier study that demonstrated treatment with ARICEPT R significantly improved cognitive function with vascular dementia compared with placebo in this double-blind study. There are currently no approved treatments for this condition.


VaD is the second most common form of dementia, accounting for up to one-third of all diagnosed dementia cases in the United States. The prevalence of VaD increases with age and, as the number of people in the U.S. age 65 and older is expected to grow to 69.4 million by the year 2030, VaD can be expected to be a growing healthcare issue in society.


The 24-week double-blind randomized study involved patients who received daily doses of either 5 milligrams (mg) ARICEPT R (donepezil hydrochloride), 10 mg ARICEPT R or placebo. Participant eligibility was defined by the NINDS-AIREN criteria. The study included 603 men and women with VaD. Most all participants took one or more medications, most frequently to prevent cardiovascular disease, with over 80 percent receiving some form of medication to prevent strokes. Patients who received ARICEPT R 5 mg or 10 mg showed significant improvement in their cognitive function compared to those taking placebo as measured by the Alzheimer's Disease Assessment Scale (ADAS-cog). Evaluation of global function also revealed significant improvements for patients at the 5 mg dose of ARICEPT R doses compared to patients who received placebo as measured by the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC plus), a standard global assessment tool. Improvement for patients on the 10 mg dose was not significantly better than placebo. These analyses are based on observed cases of patients who had a final evaluation at Week-24. Overall adverse events in VaD patients treated with ARICEPT R did not differ significantly in frequency compared to Alzheimer's disease patients. As expected and consistent with the drug's known mechanism of action, side effects related to the digestive system (including diarrhea and nausea) occurred more frequently in ARICEPT R treated patients than placebo treated patients. Of the 125 patients who discontinued the study, 89 did so due to an adverse event.


This study is one of two conducted to examine the efficacy and safety of ARICEPT R in patients with VaD for the purpose of filing with regulatory authorities in the U.S. and Europe for an indication to treat VaD. In addition, Eisai Co., Ltd. will work with its strategic alliance partner, Pfizer Inc., to file both studies in their respective territories.


ARICEPT R is an acetylcholinesterase inhibitor and was discovered and developed by Eisai Co., Ltd. ARICEPT R increases a neurotransmitter in the brain, acetylcholine serving to improve the symptoms associated with Alzheimer's disease. ARICEPT R has been launched in over 50 counties worldwide including Japan, the U.S., the U.K., Germany, and France.


Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisiai actively participates in all aspects of the worldwide health care system. The Company reported sales of over $2.9 billion in 2000 with approximately 14 percent of sales spent for research and development.



ARICEPT R is a registered trademark of Eisai Co., Ltd.





EXPLANATION OF TERMS

NINDS-AIREN Criteria : National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences Criteria
Criteria to define vascular dementia as involving memory loss, as well as impairment in at least two other cognitive domains, including orientation attention, language-verbal skills, visuo-spatial abilities, calculations, executive functions, motor control, praxis, abstraction, and judgment, that interfere with activities of daily life over and above other consequences of cerebral vascular disease (CVD).
ADAS-cog : Alzheimer's Disease Assessment Scale
Frequently used 11-item scale developed to assess the severity of cognitive impairment and the cognitive items include: spoken language ability, comprehension of spoken language, word-finding difficulty in spontaneous speech, following commands, naming objects and fingers, constructional praxis, ideational praxis, orientation, word-recall task, word recognition task, and recall of test instructions. Scores range from 0 to 70 points and lower scores indicate less severe impairment.
CIBIC plus : Clinician's Interview-Based Impression of Change with caregiver input
Semi-structured interview, performed first with the caregiver and then with the patient, to provide an overall (global) assessment of change from baseline; allows physicians to assess the patient's overall (global) response to treatment. This instrument examines the four major areas of patient function: general, cognitive, behavioral, and activities of daily living. Subsequent to baseline, the CIBIC plus change scores are rated on a 7-point scale where 1 equals marked improvement, 2 equals moderate improvement, 3 equals minimal improvement, 4 equals no change, 5 equals minimal worsening, 6 equals moderate worsening, and 7 equals marked worsening.